How to ensure the quality and supply of drugs with 4 + 7 price cut?

On the evening of December 9, CCTV financial channel reported in detail the centralized drug purchase organized by the state In the report, the relevant leaders of the medical insurance bureau responded to the situation of drug price reduction and the profit space of the enterprise ▍ there is enough space for drug price reduction According to CCTV finance and economics report, there are 25 drugs to be selected in the pilot 11 cities for volume purchase Compared with the lowest purchase price of the same kind of drugs in these pilot cities last year, the average price of the proposed drugs to be selected has dropped by 52%, and the highest drop is 96% left and right (picture source: CCTV finance and Economics) it is understood that this time, the decentralized drug purchase volume of public medical institutions in 11 pilot cities will be concentrated to form the effect of large-scale group purchase, which will significantly reduce the drug price, effectively reduce the burden of patients' drug costs, and also help reduce the cost of cross regional market promotion of enterprises Ding Yilei, deputy director of the drug price and recruitment department of the National Health Insurance Bureau, said that the economic scale effect is large, and the production cost of single products will be reduced In the past, there was still a certain gray space when drugs entered the hospital for use at the terminal Because this volume purchase is a guarantee for supply, enterprises do not need gray space to ensure sales, which is also the source of price reduction space He said that in the past, the average cycle of drug payment collection was from three months to six months, some even more than one year As we all know, if an enterprise goes to the capital market, these funds are loaned by the bank, and its one-year loan interest rate is relatively high In fact, through the guarantee of timely payment collection, the financing cost of the enterprise is reduced, which will eventually be transmitted to the terminal drug price ▍ the price drop is as high as 95% Take 0.5mg of entecavir dispersible tablets produced by Zhengda Tianqing company as an example The proposed price is 0.62 yuan / tablet, with a drop of more than 95%, which makes the industry immediately furious At the same time, another company offered 0.57 yuan / capsule, but failed to win the bid, which also became the focus of public opinion According to the provisions of "4 + 7 urban centralized drug purchase document", the applicant must quote according to the minimum purchase unit (i.e the minimum retail package, such as box) of the master product specification, and the price of the same product of the same enterprise must conform to the price difference comparison rules The applicant shall also provide a list of the varieties that meet the application conditions after being selected The purchase price shall be determined based on the master product quotation and calculated according to the price comparison rules At the same time, if it is stipulated that the number of enterprises with the same variety meeting the application conditions is more than or equal to 2, and the lowest quotation is only one enterprise, the declared variety of the enterprise will obtain the pre winning qualification It can be said that the document explicitly refers to the situation of differential price and the issue of winning the bid with the lowest quotation Therefore, in terms of absolute value, it must be 0.57 ＜ 0.62, but their dosage forms are one capsule and one dispersible tablet, which requires differential valence calculation According to the price difference rule, the relationship among tablet, capsule and dispersible tablet is 1:1:1.2, and the price of dispersible tablet converted into capsule is 0.52 yuan / tablet, so Zhengda Tianqing wins at a relatively low price, which is fully in line with the regulations (picture source: CCTV finance and Economics) it is understood that entecavir of Zhengda Tianqing was listed in 2010 After years of academic promotion, it has won the recognition of doctors and patients At present, its market share is more than 50% The enterprise not only recovers the high R & D cost, but also obtains certain profits After years of continuous operation, the initial investment is gradually amortized, the technology is becoming mature, and the manufacturing cost is reduced For the final bidding price that is much lower than the current market price, Zhengda Tianqing said that it was determined to reduce the price after careful research and repeated calculation, so as to maximize the benefits for patients and give back to the society In addition, striving to win the bid is also to maintain the leading position established by the company in the field of liver disease for many years, and to provide patients with medicines with reliable quality and low price ▍ the original research substitution realized that only two multinational enterprises, AstraZeneca's gefitinib tablets and Squibb's fosinopril sodium tablets, have achieved a price reduction of 76% and 68%, respectively, in the result of the proposed selection of 11 cities' volume procurement (photo source: CCTV Finance) according to CCTV finance, the prices of gefitinib and fosinopril sodium are more than 25% lower than those of neighboring countries and regions In this way, it really reflects the price reduction of the original research drug to a certain extent However, there are also experts in the industry who have said to cypress blue that 25 products are to be selected in this volume purchase, only two of the original research drugs of multinational pharmaceutical enterprises According to the current situation, the original research manufacturers have been successfully squeezed out, basically replacing the original research with generic drugs through consistency evaluation, but the price reduction of the original research drugs has not been realized ▍ how to ensure the production capacity and quality? In fact, the 11 pilot cities organized by the state for centralized drug procurement have accounted for about 1 / 3 of the national drug market In the face of such a large demand, can the winning enterprises provide drugs in time? How will the quality of drugs be guaranteed? The head of the state health insurance bureau said that in the implementation of the results of the selection, the State Food and Drug Administration and other departments will take effective measures to ensure the quality and supply of the selected drugs, strengthen the quality supervision over the whole cycle of production, circulation and use of key varieties, improve the frequency of sampling, and increase the intensity of accountability for enterprises violating laws and regulations In addition, enterprises are also required to establish inventory and shutdown reporting system, standardize distribution behavior through agreements, and ensure supply stability For the problem of capacity supply and quality assurance after winning the bid, most of the winning varieties have already been prepared Taking Zhengda Tianqing as an example, the company has a perfect quality assurance and quality system Many production lines have passed the certification of EU or US FDA At the same time, all raw materials of entecavir are produced by the company itself The existing capacity of entecavir production line can completely supply the national market, and the quality is controllable Zhengda Tianqing has also said that the enterprise has the ability to guarantee the national supply of drugs, not to cut prices, not to degrade quality, and to provide patients with first-class quality and low price good products The new area of Zhengda Tianqing Haizhou preparation, which has been built and put into use by Zhengda Tianqing, is designed and constructed in accordance with the new version of GMP of China and the GMP standards of the United States and the European Union It fully adopts the advanced pharmaceutical technology, process and equipment at home and abroad, embodies the "new, special and refined", and reaches the "leading level in China and the world" It is the new GMP certification of Zhengda Tianqing preparation products And access to the international high-end market provides full guarantee With reference to the design concept of the latest international technology, Zhengda Tianqing ensures the stability of product quality to the greatest extent and greatly improves production efficiency Not only in production, but also in recent years, the inspection center of Zhengda Tianqing has successively added high-performance liquid chromatograph, gas chromatograph and atomic absorption spectrometer imported from Germany, Japan, the United States and other countries To ensure that Zhengda Tianqing has passed the factory inspection for many years, and 100% of the products have passed the spot inspection ▍ is enterprise R & D innovation affected? Nowadays, the price increase of APIs is a serious problem With the input cost of consistency evaluation, the cost of enterprises is also rising dramatically Now, the price of pharmaceuticals has dropped significantly, will it hinder the development of enterprises? According to CCTV finance and economics report, the representatives of the enterprises to be selected said that the centralized purchase of national drugs is a major change, which forces enterprises to transform as soon as possible and take the road of innovative drugs and generic brand For the generic pharmaceutical enterprises winning the bid in this volume procurement, in addition to ensuring the quality and production capacity, it is very important to continue to maintain innovation when the price of the winning products drops For example, Zhengda Tianqing, although the price of entecavir dispersive tablets will decline, and the income and profit will be greatly reduced in the short term, but this will not affect its innovation The company will continue to maintain the R & D cost input of no less than 10% of annual sales revenue, and adhere to product R & D innovation Ding Jinxi, a professor at China Pharmaceutical University, said that the impact of this centralized procurement on the entire pharmaceutical industry is a milestone and a watershed In his view, it can even be raised to such a height that the country sends a very strong signal that China is gradually moving from a pharmaceutical power to a pharmaceutical power On this road, the innovation of domestic enterprises is particularly important.